VISIA DV
Nchi: Italia
Lugha: Kiitaliano
Chanzo: Ministero della Salute
Tabia za bidhaa
(SPC)
10-05-2024
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Inapatikana kutoka:
INVENTIS SRL
Idhini hali ya:
N
Idhini ya tarehe:
2011-04-01
Tabia za bidhaa
4
GB
PRODUCT DESCRIPTION
SPONGOSTAN™ Absorbable Haemostatic Gelatin
Sponge is a sterile, water-insoluble, malleable, porcine
gelatin absorbable sponge intended for haemostatic
use by applying to a bleeding surface. The sponge is
off-white and porous in appearance.
ACTIONS
When used in appropriate amounts SPONGOSTAN™
Sponge is absorbed completely within 4 to 6 weeks. In
an animal implantation study, tissue reactions were
classified as negligible when observed macroscopically,
and moderate when observed microscopically with
SPONGOSTAN™ Sponge. When applied to bleeding
mucosal regions, it liquefies within 2 to 5 days.
INTENDED USE/INDICATIONS
SPONGOSTAN™ Sponge, used dry or saturated with
sterile sodium chloride solution, is indicated for surgical
procedures (except ophthalmic) for haemostasis, when
control of capillary, venous and arteriolar bleeding by
pressure, ligature and other conventional procedures
is ineffective or impractical. Although not necessary,
SPONGOSTAN™ Sponge can be used with thrombin to
achieve haemostasis.
†
CONTRAINDICATIONS
Do not use SPONGOSTAN™ Sponge in closure of skin
incisions because it may interfere with the healing
of skin edges. This interference is due to mechanical
interposition of gelatin and is not secondary to intrinsic
interference with wound healing.
Do not use SPONGOSTAN™ Sponge in intravascular
compartments because of the risk of embolization.
Do not use SPONGOSTAN™ Sponge in patients with
known allergies to porcine collagen.
WARNINGS
• SPONGOSTAN™ Sponge is not intended as a
substitute for meticulous surgical technique and the
proper application of ligatures or other conventional
procedures for haemostasis.
• SPONGOSTAN™ Sponge should not be used in the
presence of infection. SPONGOSTAN™ Sponge
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